There is an increasing concern over counterfeit over-the-counter and prescription drugs entering the U.S. market. This concern is exacerbated because of the ready availability of lower cost prescription drugs from pharmacies and drug stores in foreign countries such as Canada.
Because of governmental regulations and/or to prevent unauthorized tampering, many prescription and over-the-counter drugs are packaged in containers using tamper-resistant seals. The consumer purchasing a drug product must break or destroy the tamper-resistant seal in order to open the container and access the product. While such tamper-resistant seals effectively thwart tampering, sophisticated counterfeit drug manufacturers may manufacture containers that include a tamper-resistant seal. Thus, tamper-resistant seals do not adequately address the issue of counterfeit drugs.
There is a need to provide an effective identification and authentication procedure to insure that a purchased drug product is authentic, beyond the use of a tamper-resistant seal on the product container. There is also a need to provide an effective method to track drug products as they move through various stages in the distribution system. Finally, there is a need to accomplish the foregoing objectives using readily available technology and equipment.